MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM11X155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64786685
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to a broken mrh stem.The mrh small femur, 11x155 cemented stem, rotating component, bushings, axle, and tibial sleeve were revised.
Additional Manufacturer Narrative
An event regarding a broken duracon stem was reported.The fractured stem could not be confirmed, however, upon review of the provided images, it appears that disassociation of a duracon stem from an mrh femoral component has occurred resulting in or as a result of wear of the stem mating section.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted fluted stem component which has worn on the mating section to a point.There are no threads visible on the mating section which is consistent with component disassociation.The device as is, would no longer be able to mate with the threaded section of the femoral component.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms stem fracture, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms stem fracture, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x- rays and examination of explanted components.The reported device was not returned however photographs were provided for review.The photographs shows a recently explanted fluted stem component which has worn on the mating section to a point.There are no threads visible on the mating section which is consistent with component disassociation.The device as is, would no longer be able to mate with the threaded section of the femoral component.Therefore, while it appears from x-ray that the device has fractured, upon review of the images provided, it would appear that the devices have disassociated with wear of the mating section of the stem evident.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's left knee was revised due to a broken mrh stem.The mrh small femur, 11x155 cemented stem, rotating component, bushings, axle, and tibial sleeve were revised.

• Brand Name: TI DUR REG FLUTED STEM11X155MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9005873
• Report Number: 0002249697-2019-03186
• Device Sequence Number: 2802360
• Product Code: JWH
• UDI-Device Identifier: 07613327044980
• UDI-Public: 07613327044980
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 64786685
• Device Lot Number: T3735
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR